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Repeatability of Quantitative Autofluorescence Imaging in a Multicenter Study Involving Patients With Recessive
Patty P A Dhooge1,2, Philipp T Möller3,4, Nils Meland5
1Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.
Translational Vision Science & Technology
|February 1, 2023
Summary
Quantitative autofluorescence (qAF) shows variability in multicenter trials for Stargardt disease 1 (STGD1). While qAF is a useful endpoint, improved training and recording selection can mitigate variability for clinical trial success.
Area of Science:
- Ophthalmology
- Medical Imaging
- Genetics
Background:
- Recessive Stargardt disease 1 (STGD1) is a leading genetic cause of macular degeneration.
- Quantitative autofluorescence (qAF) is a promising imaging biomarker for STGD1.
- Assessing qAF repeatability in multicenter settings is crucial for its clinical trial application.
Purpose of the Study:
- To evaluate the repeatability of quantitative autofluorescence (qAF) in a multicenter setting for STGD1.
- To assess the suitability of qAF as a clinical trial endpoint in STGD1.
Main Methods:
- 102 STGD1 patients underwent qAF imaging across multiple sites.
- 166 eyes were imaged twice, with two recordings per visit.
- Reproducibility was assessed using intraclass correlation (ICC) and Bland-Altman analysis.
Main Results:
- Intra-visit qAF repeatability was ±26.1%, inter-visit was ±40.5%, and interobserver was ±20.2%.
- Intra-visit repeatability was good to excellent (ICC 0.88-0.96), while inter-visit repeatability was moderate (ICC 0.76).
- No significant difference in qAF values was observed across sites between visits.
Conclusions:
- Real-world qAF test-retest variability is higher than in single-center studies.
- qAF is a viable method for assessing autofluorescence changes in STGD1.
- Consideration of variability mitigation strategies is recommended for adopting qAF as a clinical trial endpoint.
